HUTCHMED(HCM) Prnewswire·2025-03-19 00:55Core Insights - The FRUSICA-2 Phase 2/3 clinical trial has successfully met its primary endpoint of progression-free survival (PFS) for the combination of sintilimab and fruquintinib in treating advanced renal cell carcinoma (RCC) in China [1][3] - The combination therapy has received conditional approval from China's National Medical Products Administration (NMPA) for advanced endometrial cancer, indicating its potential in multiple cancer types [2][11] - The study demonstrated improvements in secondary endpoints, including objective response rate (ORR) and duration of response (DoR), with full results expected to be presented at a scientific conference [3] Company Overview - Innovent Biologics, Inc. is a biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune conditions [1][18] - HUTCHMED (China) Limited is committed to the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [21][22] - Both companies are collaborating to advance the registrational communication of the sintilimab and fruquintinib combination therapy [4][5] Clinical Trial Details - The FRUSICA-2 study is a randomized, open-label trial comparing sintilimab and fruquintinib against axitinib or everolimus monotherapy for second-line treatment of advanced RCC [3][16] - The trial's positive results are seen as a significant advancement in treatment options for patients who have not responded adequately to previous therapies [4][5] Market Context - In 2022, approximately 435,000 new kidney cancer cases were diagnosed globally, with 74,000 in China, highlighting the substantial market potential for effective treatments [5] - The combination of sintilimab and fruquintinib addresses an unmet medical need for advanced RCC patients who have previously failed single-agent targeted therapies [16][17]